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X4 Pharmaceuticals Reports Fourth-Quarter and Full-Year 2022 Financial Results and Provides Corporate Update
Upcoming expected milestones for investigational therapy mavorixafor in WHIM syndrome include: presentation of additional Phase 3 clinical data in 2Q 2023,
About this update from X4 Pharmaceuticals, Inc.
[{"type":"text","content":"Upcoming expected milestones for investigational therapy mavorixafor in WHIM syndrome include: presentation of additional Phase 3 clinical data in 2Q 2023, NDA submission in early 2H 2023, and potential U.S. launch in 1H 2024 Announcement of data from ongoing chronic neutropenia Phase 2 trial and clarity on regulatory path forward planned in 2Q or 3Q 2023 Conference call to be hosted today at 9:00 a.m. ET BOSTON, March 21, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a leader in the discovery and development of novel small-molecule therapeutics to benefit people with diseases of the immune system, today reported financial results for the fourth quarter and full year ended December 31, 2022 and highlighted key 2022 events and expected upcoming milestones. “We could not be more pleased with the progress we made in 2022 advancing our investigational therapy, mavorixafor, towards commercialization,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. “Our clinical trial data continue to speak for themselves, demonstrating mavorixafor’s ability to elevate circulating levels of neutrophils, lymphocytes, and monocytes in people with immune system dysfunction. Following the positive results from our 4WHIM clinical trial in late 2022, we continue to expect presentation of additional Phase 3 data in the second quarter of 2023 and the submission of our first New Drug Application (NDA) in the U.S. early in the second half of the year. We are now enrolling patients in our Phase 2 trial in people with certain chronic neutropenic (CN) disorders and anticipate announcing clinical data from this trial along with clarity on the potential regulatory path forward for mavorixafor in CN disorders in the second or third quarter of 2023.” 2022 Highlights & Key Anticipated Upcoming Milestones Positive Clinical Results: With a tightened focus on advancing mavorixafor in chronic neutropenia indications, X4 announced successful conclusion of and positive data from key clinical programs in 2022: Pivotal, Phase 3 4WHIM trial: In late November, the company announced that its Phase 3 clinical trial evaluating oral mavorixafor in people with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome met its primary endpoint and first key secondary endpoint, with mavorixafor achieving statisticall...